Access to inventions in EU emergencies

On 19^thJanuary 2026, Regulation 2025/2645 of 16 December 2025 on compulsory licensing for crisis management (the "Regulation") entered into force. This Regulation implements a legal framework to apply compulsory licenses to inventions related to "crisis-relevant products" (the "Products") to effectively respond to emergencies and crisis situations at the Union level.

According to the Explanatory memorandum accompanying the European Commission’s proposal for the Regulation (the "Proposal"), the COVID-19 crisis highlighted the need to enhance and reconcile the system of compulsory licensing. This event underscored the importance of striking a fair balance between patent rights and other rights and interests. The Regulation is part of a set of measures designed to provide the Union with adequate instruments to address crisis situations, complementing these tools by enabling public intervention where voluntary approaches of other instruments are unavailable or inadequate.

Context and purpose

European Union Member States have implemented legal regimes regulating compulsory licensing within their respective jurisdictions (in Spain, these are provided for in Articles 91 et seq. of Act 24/2015, of 24 July, on Patents).

In essence, compulsory licenses represent an exception to the principle of free negotiation between operators, allowing for public authority intervention under exceptional circumstances. The public intervention system aims to ensure an adequate balance between the rights and interests at stake. In this regard, the Proposal clarified that, during the COVID-19 crisis, a conflict arose between ensuring access to essential health products and maintaining incentives for innovation, which are crucial for the development of new health products.

The Regulation recognizes that the exceptional circumstances that require its application transcend borders and require a coordinated response at the European Union level. Hence, the need to create a harmonized legal framework among Member States.

Scope of compulsory licensing

The rights subject to compulsory licensing include:

• Patents and published patent applications;
• Utility models and published applications for utility models; and
• Supplementary protection certificates.

Intellectual property rights (copyrights and related works), trade secrets, and defense-related products are explicitly excluded.

Accordingly, the framework established by the Regulation applies to healthcare-related products such as medicines and other therapeutic options.

The framework introduced by this Regulation is exceptional in nature. Compulsory licenses may only be granted to achieve specific objectives, particularly to carry out “the specific measures related to crisis-relevant products provided for in the relevant Union crisis or emergency mechanism and in the context of a declared crisis or emergency mode.”

General conditions and requirements (acope)

Granting a compulsory license under the Regulation requires the cumulative presence of the following circumstances:

• The Union has declared a crisis or emergency mode.
• The European Commission concludes that the use of an invention regarding the Product is necessary to supply said Product within the Union.
• There are no other less burdensome means to ensure effective supply of the Products within a reasonable timeframe (measure of last resort).
• The holder of the invention is guaranteed the opportunity to submit observations regarding this measure.

Compulsory licenses granted will be non-exclusive, non-transferable, and have limited scope:

• Material: Only to fulfill the purpose for which the license was granted, in light of the specific crisis or emergency situation, and enabling the necessary exploitation activities to ensure the supply of Products.
• Territorial: Limited to the Union’s territory, with explicit prohibition of exporting Products manufactured or marketed under the license.
• Temporal: Valid until the end of the crisis or emergency situation.

The licensee must demonstrate the capability to properly exploit the invention in response to the crisis or emergency situation and is required to pay an adequate remuneration to the rights holder. This remuneration will be determined by the European Commission, taking into account “the economic value of the relevant activities authorised under the Union compulsory licence, as well as the circumstances of each case, such as any public support received to develop the protected invention.”

Grant procedure

The procedure involves the following milestones:

• Announcement in the Official Journal of the European Union (OJEU), identifying the Products, the rights protecting them, and their holders.
• The European Commission invites observations from the affected rights holders, potential licensees, and other stakeholders.
• Based on received observations, a (non-binding) opinion is issued evaluating the necessity and scope of the compulsory license.
• Based on this opinion, the European Commission decides whether to proceed with the procedure and, if so, notifies the rights holder, inviting further observations.
• If the conditions of the Regulation are met, the European Commission proceeds to grant the compulsory license.

Throughout the procedure, both the licensor and the licensee are required to cooperate and refrain from obstructing the compulsory licensing process. It is also noteworthy that the procedure does not preclude the possibility for the parties involved to enter into voluntary licensing agreements for the Product at any stage.

Licensee obligations

Among other obligations prescribed in the Regulation, the licensee must ensure that the Products are manufactured or marketed in sufficient quantities, distributed appropriately, and distinctly identified with specific labeling that differentiates them from products manufactured or distributed under a voluntary license.

Failure to comply with these obligations may result in either the revocation of the compulsory license or the imposition of fines ranging from €50,000 to €300,000. The imposition of such fines requires deliberate or negligent non-compliance with the license terms, along with consideration of the specific circumstances in each case.

Amendment of Regulation 816/2006

In addition, the Regulation introduces three new articles into Regulation 816/2006 on compulsory licensing of patents relating to the manufacture of pharmaceutical products for export to countries with public health problems. The objective is to enable the use of Union compulsory licenses in specific public health crisis situations, particularly with respect to manufacturing pharmaceutical products intended for export to countries facing public health challenges.

For more information, please contact our specialists through the Knowledge and Innovation Area.